Expandable tissue engagement apparatus and method

ABSTRACT

A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes an expandable structure for enhancing engagement with median lobe prostate tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Application Serial No.PCT/US18/67229 filed Dec. 21, 2018, which claims priority to U.S.Provisional Application Ser. No. 62/610,184, filed Dec. 23, 2017,entitled “Median Lobe Engagement Apparatus and Method,” each of which isincorporated herein by reference.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to medical devices and methods,and more particularly to systems and associated methods for manipulatingor engaging tissues and anatomical or other structures within the bodyof human or animal subjects for the purpose of treating diseases ordisorders.

One example of a condition where it is desirable to lift, compress, orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra as a result of the glandenlarging. This pressure on the urethra increases resistance to urineflow through the region of the urethra enclosed by the prostate. Thus,the urinary bladder has to exert more pressure to force urine throughthe increased resistance of the urethra. Chronic over-exertion causesthe muscular walls of the urinary bladder to remodel and become stiffer.This combination of increased urethral resistance to urine flow andhypertrophy and stiffness of urinary bladder walls leads to a variety oflower urinary tract symptoms (LUTS) that may severely reduce thepatient's quality of life. These symptoms include weak or intermittenturine flow while urinating, straining when urinating, hesitation beforeurine flow starts, feeling that the bladder has not emptied completelyeven after urination, dribbling at the end of urination or leakageafterward, increased frequency of urination particularly at night, andurgent need to urinate.

In addition to being present in patients with BPH, LUTS may also bepresent in patients with prostate cancer, prostate infections, andchronic use of certain medications (e.g. ephedrine, pseudoephedrine,phenylpropanolamine, and antihistamines such as diphenhydramine orchlorpheniramine) that cause urinary retention especially in men withprostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery, andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients who have minimal symptoms that are not especially bothersome.

Medical procedures for treating BPH symptoms include TransurethalResection of the Prostate (TURP), Transurethral Electrovaporization ofthe Prostate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy, Open Prostatectomy, Transurethral Microwave Thermotherapy(TUMT), Transurethral Needle Ablation (TUNA), Interstitial LaserCoagulation (ILC), and Prostatic Stents.

The most effective current methods of treating BPH in terms of relievingthe symptoms of BPH also carry a high risk of adverse effects. Thesemethods may require general or spinal anesthesia and/or may havepotential adverse effects that dictate that the procedures be performedin a surgical operating room, followed by a hospital stay for thepatient. The methods of treating BPH that carry a lower risk of adverseeffects are also associated with a lower reduction in the symptom score.While several of these procedures can be conducted with local analgesiain an office setting, the patient does not experience immediate reliefand, in fact, often experiences worse symptoms for weeks after theprocedure until the body begins to heal. Additionally, many surgical orminimally invasive approaches require a urethral catheter to be placedin the bladder, and in some cases left in the bladder for weeks. In somecases, catheterization is indicated because the therapy actually causesobstruction during a period of time post operatively, and in other casesit is indicated because of post-operative bleeding and the potential forthe formation of occlusive clots. While drug therapies are easy toadminister, the results are frequently suboptimal, take significant timeto take effect, and often include undesirable side effects.

There have been advances in developing minimally invasive devices andmethods for displacing and/or compress lobes of a prostate gland toreceive pressure on and provide a less obstructed path through aurethra. These methods have focused on treating the lateral lobes of theprostate gland. There remains, however, a need for the development ofnew devices and methods that can be used for various procedures where itis desired to lift, compress, support, or reposition the median lobe ofa prostate in a discrete procedure or in combination with treating BPH.In particular, there is a need for alternative apparatus and treatmentapproaches for the purpose of manipulating the median lobe of aprostate.

Still further, there is an ongoing need in the field of minimallyinvasive medical devices for devices and methods for the manipulation oftissue in other parts of the anatomy.

The present disclosure addresses these and other needs.

SUMMARY

Embodiments of the invention include a treatment device for engaging andmanipulating a median lobe of a prostate gland. The treatment deviceincludes an elongate tissue access assembly coupled to a handleassembly, wherein the elongate tissue access assembly is configured tobe inserted within an introducer sheath, and a tissue engagementstructure attached to a distal end portion of the elongate tissue accessassembly, wherein the tissue engagement structure can transition from acontracted state to an expanded state when the elongate tissue accessassembly exits a distal end of the introducer sheath.

In another embodiment of the invention, the tissue engagement structurecomprises a first expandable portion having an asymmetricalcross-section. In another embodiment of the invention, a proximalportion of the first expandable portion is attached to the elongatetissue access assembly. In another embodiment of the invention, thetissue engagement structure comprises a channel to receive the distalend portion of the elongate tissue access assembly. In anotherembodiment of the invention, movement of the tissue engagement structurerelative to the elongate tissue access assembly is constrained to bealong a longitudinal axis of the elongate tissue access assembly. Inanother embodiment of the invention, movement of the tissue engagementstructure relative to the elongate tissue access assembly transitionsthe tissue engagement structure from the contracted state to theexpanded state. In another embodiment of the invention, the elongatetissue access assembly further comprises an aperture and a needleassembly that is extendable through the aperture. In another embodimentof the invention, the tissue engagement structure further comprises afirst visual marker indicating a tissue entry position for the needleassembly. In another embodiment of the invention, the tissue engagementstructure further comprises a second expandable portion having anasymmetrical cross-section. In another embodiment of the invention,wherein the elongate tissue access assembly further comprises anaperture and a needle assembly that is extendable through the aperture.

Embodiments of the invention include, a system for engaging andmanipulating a median lobe of a prostate gland such that the systemincludes an anchor delivery device comprising an elongate tissue accessassembly, wherein the elongate tissue access assembly is configured tobe inserted within an introducer sheath, a tissue anchor housed withinthe anchor delivery device, and a tissue engagement structure attachedto a distal end portion of the elongate tissue access assembly, whereinthe tissue engagement structure can transition from a contracted stateto an expanded state. In another embodiment of the invention, the tissueengagement structure comprises a first expandable portion having anasymmetrical cross-section. In another embodiment of the invention, aproximal portion of the first expandable portion is fixedly attached tothe elongate tissue access assembly. In another embodiment of theinvention, the tissue engagement structure comprises a slidable portioncoupled to the elongate tissue access assembly. In another embodiment ofthe invention, movement of the tissue engagement structure relative tothe elongate tissue access assembly transitions the tissue engagementstructure from the contracted state to the expanded state. In anotherembodiment of the invention, the anchor delivery device furthercomprises a needle assembly. In another embodiment of the invention, theneedle assembly is configured to deliver the tissue anchor. In anotherembodiment of the invention, the tissue engagement structure comprises afirst expandable portion. In another embodiment of the invention, thefirst expandable portion further comprises a first visual markerindicating a tissue entry position for the needle assembly. In anotherembodiment of the invention, the tissue engagement structure furthercomprises a second expandable portion.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view, depicting anatomy in the areasurrounding a prostate in a human subject.

FIG. 2 is an enlarged cross-sectional view of an area of FIG. 1,depicting anatomy immediately surrounding and adjacent a prostate.

FIG. 3 is a schematic view, depicting prostatic anatomy zones.

FIG. 4 is a schematic cross-sectional view, depicting further details ofthe anatomy zones shown in FIG. 3.

FIG. 5 is a cross-sectional view, depicting a normal prostate.

FIG. 6 is a cross-sectional view, depicting a prostate with enlargedlateral lobes.

FIG. 7 is a cross-sectional view, depicting a prostate with enlargedlateral lobes and an enlarged median lobe.

FIG. 8A is a side view, depicting an embodiment of a delivery device;

FIG. 8B is an enlarged perspective view, depicting the distal end of anembodiment of a delivery device.

FIG. 9A is a top view, depicting an embodiment of an expandablestructure that can be employed to engage and manipulate tissue.

FIG. 9B is a perspective view, depicting an embodiment of an expandablestructure that can be employed to engage and manipulate tissue.

FIG. 9C is an enlarged view, depicting an embodiment of an expandableengagement and manipulation device mounted on the distal end of anembodiment of a delivery device.

FIG. 10 is a perspective view, depicting another embodiment of anexpandable structure that can be employed to engage and manipulatetissue.

FIG. 11 is a perspective view, depicting another embodiment of anexpandable structure that can be employed to engage and manipulatetissue.

FIG. 12A is a top perspective view, depicting an embodiment of anexpandable engagement and manipulation device.

FIG. 12B is an enlarged top perspective view, depicting a distal endportion of an expandable engagement and manipulation device.

FIG. 12C is a perspective view, depicting another embodiment of anexpandable structure that can be employed to engage and manipulatetissue.

FIG. 12D is an enlarged bottom perspective view, depicting a distal endportion of an embodiment of an expandable engagement and manipulationdevice.

FIG. 12E is an enlarged bottom view, depicting a distal end portion ofan embodiment of an expandable engagement and manipulation device.

FIG. 12F is an enlarged side view, depicting a distal end portion of anembodiment of an expandable engagement and manipulation device.

FIG. 12G is a cross-sectional view, depicting a distal end portion of anembodiment of an expandable engagement and manipulation device.

FIG. 13A is a top view, depicting an embodiment of an expandablestructure with telescoping arms that can be employed to engage andmanipulate tissue.

FIGS. 13B-D are various partial perspective views, depicting telescopingarms of an expandable structure that can be employed to engage andmanipulate tissue.

FIGS. 14A-B are cross-sectional views, depicting alternativeconfigurations for telescoping arms.

FIGS. 15A-D are various cross-sectional views, depicting details of anapproach to engaging, compressing and manipulating a median prostatelobe of a prostate.

FIG. 16A is a perspective view, depicting a distal end portion of anexpandable structure that can be employed to engage and manipulatetissue housed in a sheath.

FIG. 16B is a perspective view, depicting the distal end portion of theexpandable structure of FIG. 16A in an expanded state after exiting thesheath.

FIG. 17A is a perspective view, depicting the distal end of a sheath.

FIG. 17B is a perspective view, depicting an expanded structure that canbe employed to engage and manipulate tissue attached to a sheath.

FIG. 18A is a perspective view, depicting an embodiment of an expandablewire structure that can be employed to engage and manipulate tissue, ina contracted state.

FIG. 18B is a perspective view, depicting an embodiment of an expandablewire structure that can be employed to engage and manipulate tissue, inan expanded state.

FIG. 19A is a perspective view, depicting another embodiment of anexpandable wire structure that can be employed to engage and manipulatetissue, in a contracted state.

FIG. 19B is a perspective view, depicting another embodiment of anexpandable wire structure that can be employed to engage and manipulatetissue, in an expanded state.

FIGS. 20A-C are enlarged perspective views, depicting a distal endportion of an expandable engagement and manipulation deviceincorporating various supplemental tissue engagement structures.

FIGS. 20D-F are enlarged perspective views, depicting a distal endportion of a tissue access and a device incorporating varioussupplemental tissue engagement structures.

FIGS. 20G-H are enlarged views, depicting structures that can beincorporated into the distal end portion of a tissue engagement andmanipulation device.

FIG. 21 is a partial cross-sectional view, depicting yet anotherapproach to engaging and manipulating target tissue.

FIG. 22 is an enlarged view, depicting further structure incorporatedinto an engagement and manipulation device.

FIG. 23 is an enlarged view, depicting supplemental structure formingpart of an engagement and manipulation device.

FIGS. 24A-B are enlarged views, depicting structures that can beincorporated into the distal end portion of a tissue engagement andmanipulation device and methods for engaging and manipulating tissue.

FIGS. 25A-B are enlarged views, depicting structures that can beincorporated into the distal end portion of a tissue engagement andmanipulation device.

FIGS. 26A-B are enlarged views, depicting structures that can beincorporated into the handle portion of a tissue engagement andmanipulation device.

FIGS. 27A-B are enlarged views, depicting other structures that can beincorporated into the distal end portion of a tissue engagement andmanipulation device.

DETAILED DESCRIPTION OF THE SEVERAL DRAWINGS

Turning now to the figures, which are provided by way of example and notlimitation, the present disclosure is directed to a device configured toengage and manipulate tissue within a patient's body for treatmentpurposes. The disclosed apparatus can be employed for various medicalpurposes including but not limited to retracting, lifting, compressing,approximating, supporting, and/or repositioning tissues, organs,anatomical structures, grafts, or other material found within apatient's body. Such tissue manipulation is intended to facilitate thetreatment of diseases or disorders, including, but not limited to, thedisplacement, compression and/or retraction of the median lobe of aprostate.

In an aspect of the present disclosure, the tissue engagement ormanipulation forms the primary interventional procedure. In otheraspects, the tissue engagement or manipulation forms one portion of aninterventional procedure, such as the treatment of BPH or for thepurpose of retracting, lifting, compressing, approximating, supportingor repositioning other anatomy or for the purpose of retracting,lifting, compressing, approximating, supporting, or repositioning afirst section of anatomy with respect to a second section of anatomy.

With reference to FIGS. 1-4, various features of urological anatomy of ahuman male subject are presented. The prostate gland PG is awalnut-sized gland located adjacent the urinary bladder UB. The urethraUT runs through the prostate gland PG and the penis P. The prostategland PG secretes fluid that protects and nourishes sperm. The prostategland PG also contracts during ejaculation to expel semen and to providea valve to keep urine out of the semen. A capsule C surrounds theprostate gland PG.

The urinary bladder UB holds urine. The vas deferentia VD define ductsthrough which semen is carried, and the seminal vesicles SV secreteseminal fluid. The rectum R is the end segment of the large intestinethrough which waste is dispelled. The urethra UT carries both urine andsemen out of the body. Thus, the urethra is connected to the urinarybladder UB and provides a passageway to the vas deferentia VD andseminal vesicles SV. The verumontanum VM is a crest in the wall of theurethra UT where the seminal ducts enter. The prostatic urethra is thesection of the urethra UT which extends through the prostate. Thetrigone T (see FIG. 3) is a smooth triangular region of the bladder. Itis sensitive to expansion and signals the brain when the urinary bladderUB is full.

The prostate gland can be classified by zones or described by referringto its lobes (See FIG. 4). Whereas the zone classification is typicallyused in pathology, the lobe classification is more often used inanatomy. The central zone (a) of a prostate gland PG is about 25% of anormal prostate and this zone surrounds the ejaculating ducts. There issome prevalence of benign prostate hyperplasia in the transition zone.The fibromuscular zone (b) is usually devoid of glandular componentsand, as its name suggests, is composed of muscle tissue and fibroustissue. The transitional zone (c) generally overlays the proximalurethra and is the region of the gland that grows throughout life. Thiszone is often associated with the condition of benign prostaticenlargement. Finally, the peripheral zone (d) is the sub-capsularportion of the posterior aspect of the prostate gland that surrounds thedistal urethra.

The lobe characterization is different from the zone characterization,but there is some overlap. The anterior lobe is devoid of glandulartissue and is formed of fibromuscular tissue. The anterior lobe roughlycorresponds to the anterior portion of the transitional zone (c). Theposterior lobe roughly corresponds to the peripheral zone (d) and can bepalpated through the rectum during a digital rectal exam. The posteriorlobe is the site of 70-80% of prostatic cancers. The lateral lobes arethe main mass of the prostate and are separated by the urethra. Allpathological zones may be present in the lateral lobes. Lastly, themedian lobe roughly corresponds to part of the central zone. It variesgreatly in size from subject to subject and in some cases is devoid ofglandular tissue.

A large or enlarged median lobe can act as a ball valve, blocking thebladder neck, or opening, into the urethra. Various approaches arecontemplated to address such a condition. It is contemplated that themedian lobe can be compressed, displaced and/or retracted to eliminateor decrease the blocking of the bladder neck opening.

Turning now to FIGS. 5-7, there are shown various prostate glands incross-section. FIG. 5 depicts the urinary bladder UB and prostate glandPG of a healthy subject. FIG. 6 illustrates an individual with aprostate having enlarged lateral lobes LL and FIG. 7 depicts a subjectsuffering from both enlarged lateral lobes LL and an enlarged medianlobe ML. It is to be appreciated that such enlarged anatomy impinges onthe urethra UT and affects normal bladder functioning. The followingdevices and approaches can be employed to access and manipulateprostatic tissue during an interventional or diagnostic procedure.

Referring now to FIGS. 8A & 8B, an embodiment of a treatment device 100is shown. Treatment device 100 can include a handle assembly 102 and anelongate tissue access assembly 104. Elongate assembly 104 can beconfigured to access an interventional site as well as engage andmanipulate target tissue. Treatment device 100 can be configured toassemble and implant one or more anchor assemblies or implants within apatient's body. The device is further contemplated to be compatible foruse with minimally invasive techniques (such as cystoscopy) such that apatient can tolerate a procedure while awake or under light sedationrather than under general anesthesia. The device additionally includesstructures configured to receive a conventional remote viewing device(e.g., an endoscope) so that the steps being performed at theinterventional site can be observed by the physician.

The elongate assembly 104 can house members to manipulate target tissueincluding, but not limited to, a needle assembly 106. Elongate assembly104 can also be equipped with features to manipulate target tissueand/or stabilize the device at its interventional site. Elongateassembly 104 can be inserted through a sheath of a size compatible withconventional cystoscopy, including sizes such as 19F or 21F. Elongateassembly 104 can be rigid or flexible. In some preferred embodiments,elongate assembly 104 is sufficiently rigid (or can be made sufficientlyrigid when at the interventional site) to allow manual compression oftissue at an interventional site by leveraging or pushing handleassembly 102. Various embodiments of treatment device 100 can includesubassemblies and components to dissect, resect, or otherwise alter aprostatic lobe.

In one particular, non-limiting use in treating a prostate, the elongatetissue access assembly of a delivery device is placed within a urethraleading to a urinary bladder of a patient. In one approach, the deliverydevice can be placed within an introducer sheath previously positionedin the urethra or alternatively, the delivery device can be inserteddirectly within the urethra. When employing an introducer sheath, thesheath can be attached to a sheath mount assembly. The sheath isadvanced within the patient until a leading end thereof reaches aprostate gland. In a specific approach, a first side (i.e., laterallobe) of the prostate to be treated is chosen while the device extendsthrough the bladder and the device is turned accordingly. The distal endof the elongate tissue access assembly can be used to depress theurethra into the prostate gland by compressing the inner prostatetissue. The inside of the prostate gland (i.e., adenoma) is spongy andcompressible and the outer surface (i.e., capsule) of the prostate glandis firm. By pivoting the elongate tissue access assembly laterally aboutthe pubic symphysis PS relative to the patient's midline, the physiciancan depress the urethra into the prostate gland compressing the adenomaand creating the desired opening through the urethra. Further detailsand background concerning related and complementary interventionalprocedures are described in various U.S. Patents, including U.S. Pat.Nos. 8,491,606 and 8,758,366, the entirety of the contents of which arehereby incorporated by reference.

When the treatment device is used at an interventional site, such as themedian lobe of the prostate, prior to deployment of an implant oralteration of prostatic tissue the median lobe often requiresmanipulation into a position conducive to receiving an implant.Embodiments of a device and method of use that can position andstabilize a treatment device to better engage and manipulate targettissue, including the median lobe of the prostate, are described below.In a preferred embodiment, such a device can include a winged,expandable/collapsible structure that increases the distal surface areaof the device to engage and manipulate tissue.

FIGS. 9A-9C illustrate an expandable member 200 that can be configuredfor attachment to the distal end of an elongate member. Expandablemember 200 can include arms 202 a and 202 b situated in parallel (orsubstantially in parallel) and connected by a distal connecting member206 at the distal end of member 200. Each arm can have a portion thatexpands outward past the longitudinal axis of arms 202 a and 202 b. Suchexpandable portions can be wings 208 a and 208 b. In some embodiments,wings 208 a and 208 b can connect to form a closed loop (not shown) inplace of distal connecting member 206. Distal connecting member 206 canbe grooved, channeled, or otherwise hollowed to create an opening 210formed therein.

Wings 208 a and 208 b can be configured to be biased to an expandedposition. In this embodiment, wings 208 a and 208 b are moved to aretracted position by moving distal connecting member 206 and/or arms202 a and 202 b in a longitudinal direction away from wings 208 a and208 b. In another embodiment, wings 208 a and 208 b are configured in aretracted position and are moved to an expanded position by movingdistal connecting member 206 and/or arms 202 a and 202 b in alongitudinal direction toward wings 208 a and 208 b. In someembodiments, each wing can be expanded or retracted independently bymoving the arm on the same side as the wing in a longitudinal directionaway from or toward the wing as the configuration requires.

The proximal end of expandable member 200 can be attached to an elongatetissue access assembly 204 by connecting arms 202 a and 202 b to theshaft of the elongate assembly. In some embodiments, elongate assembly204 is inserted through expandable member 200 such that theinwardly-facing side 212 a of arm 202 a and inwardly-facing side 212 bof arm 202 b are flush with a portion of the outwardly-facing sides 214a and 214 b of elongate assembly 204 and secured via welding or otherconventional means of attachment. The distal end of expandable member200 can interact with a portion of the distal end of elongate assembly204. For example, opening 210 can be configured to snap into, or beotherwise secured by, elongate assembly 204. As illustrated in FIG. 9C,elongate assembly 204 can include tabs 216 a and 216 b removablyfastened over distal connecting member 206 thereby holding the distalend of expandable member 200 in place. In some embodiments, such as whenelongate assembly 204 includes an aperture 220, wings 208 a and 208 bcan be positioned in any plane relative to the aperture. Further, wings208 a and 208 b may be in the same plane with respect to each other ormay be positioned at an angle with respect to each other. In someembodiments, the angle between the plane of the wings is adjustable. Insome embodiments, the elongate assembly is configured such that atreatment assembly, such as a needle assembly, is extendable through theaperture.

In some embodiments, expandable member 200 can be delivered using asheath. The sheath functions to house expandable member 200 and collapseor compress wings 208 a and 208 b as the device is delivered to aninterventional site of a patient. Once the target site is reached,extension of expandable member 200 through the distal opening of thesheath can be actuated by the handle assembly of the treatment device.As expandable member 200 exits the sheath, wings 208 a and 208 b expandor spring open, move away from the midline, to contact and manipulatetarget tissue. This delivery maintains wing alignment while preventingtissue trauma due to the wing edges. According to one embodiment, arms202 a and 202 b are fixedly secured to elongate assembly 204 and distalconnecting member 206 is free to move longitudinally with respect towings 208 a and 208 b to enable expansion and retraction of wings 208 aand 208 b as they exit the sheath. According to another embodiment, arms202 a and 202 b are free to move longitudinally with respect to wings208 a and 208 b and distal connecting member 206 is fixedly secured toelongate assembly 204 to enable expansion and retraction of wings 208 aand 208 b as they exit the sheath.

FIG. 10 shows another embodiment of an expandable member that can beattached to the distal end of a treatment device. Expandable member 300can include arms 302 a and 302 b situated in parallel or substantiallyin parallel. Each arm can include a portion that is capable of expandingoutward past the longitudinal axis of arms 302 a and 302 b. Wings 308 aand 308 b can be connected to a distal attachment piece 306 at thedistal end of expandable member 300. In one embodiment, distalattachment piece 306 is horseshoe-shaped. Distal attachment piece 306can be situated in a substantially perpendicular configuration withrespect to wings 308 a and 308 b. Distal attachment piece 306 caninclude tabs 310 a and 310 b. Attachment piece 306 can be configured toreceive and form a secure connection with a portion of the distal end ofa treatment device.

FIG. 11 shows another embodiment of an expandable member. Expandablemember 400 can include arms 402 a and 402 b situated in parallel orsubstantially in parallel. Each arm can include a portion that iscapable of expanding outward past the longitudinal axis of arms 402 aand 402 b. Wings 408 a and 408 b can terminate with curved ends 410 aand 410 b, respectively, that connect to create channel 406. Channel 406can be configured to receive and secure a portion of the distal end of atreatment device.

FIGS. 10 and 11 illustrate configurations of the distal end of theexpandable member that facilitate attachment of the expandable member toa treatment device. Other configurations that facilitate attachment ofthe expandable member to a treatment device are contemplated and thedisclosure herein is not limited to the attachment configurationsdepicted in FIGS. 10 and 11.

Referring again to the embodiment of a treatment device depicted inFIGS. 8A-B, the device is configured such that the needle actuator 108and the needle retracting lever 110 are in a ready position capable ofproviding treatment, such as delivery of a tissue anchor. Upondepression of the needle actuator 108, the needle assembly 106 isadvanced from within the elongate tissue access assembly 104 (See FIG.8B). The needle assembly can be configured so that it curves back towardthe handle as it is ejected. In use in a prostate intervention, theneedle assembly is advanced through and beyond a prostate gland. Springdeployment helps to ensure the needle passes swiftly through the toughouter capsule of the prostate without “tenting” the capsule or failingto pierce the capsule.

After depression of the needle actuator 108 and the unlocking of theneedle retraction lever 110, the needle retraction lever 110 can beactuated. Such action results in a withdrawal of the needle assembly106. In some embodiments, the needle assembly 106 is withdrawn furtherthan its original position within the device pre-deployment. In aprostatic interventional procedure, this action can be used to deliveran implant or various activatable members, such as a tissue anchor, tofacilitate modification of prostatic tissue.

The expandable member can be used to position elongate tissue accessassembly 104 such that it engages the median lobe prior to and duringdeployment of an implant and/or modification of prostatic tissue byincreasing the surface area of the distal end of assembly 104. Theexpandable member can also be used to displace and widen the urethralwall.

As shown in FIGS. 12A-G, an elongate assembly 450 can include a distalend 452 with an expandable member 460. Expandable member 460 can includearms 462 a and 462 b situated in parallel and secured to the shaft ofdistal end 452. Each arm can include an expandable portion, wings 464 aand 464 b, that expand outward past the longitudinal axis of arms 462 aand 462 b. The distal end of expandable member 400 can include channel466 to receive and secure a portion of the distal end of elongateassembly 450. FIGS. 12F & 12G illustrate a cross-section of channel 466with tabs 468 a and 468 b that fasten over a portion of the distal end452 of elongate assembly 450. Insertion of the elongate assembly 450into channel 466 allows the distal end of expandable member 460 to slidealong the shaft of the assembly and facilitate wing position from a“closed” (compressed toward the midline) to an “open” (displaced awayfrom the midline) configuration. Additionally, movement of expandablemember 460 relative to the treatment device is constrained to thelongitudinal axis of the treatment device. Furthermore, such analignment presents no additional obstruction to cystoscope or endoscopeview when such viewing devices are used during a procedure.

When elongate assembly 450 is inserted into a sheath (not shown), suchas when the device is delivered to an interventional site of a patient,wings 464 a and 464 b reduce in profile by collapsing toward the midlineof the longitudinal axis of the distal end the treatment device. Oncethe target site is reached, wings 464 a and 464 b can expand away fromthe midline of the treatment device when the elongate assembly 450 isextended through the distal opening of the sheath. Wings 464 a and 464 bare then available to engage and manipulate tissue.

In some embodiments, expandable member 460 is made from stainless steelhaving a 0.006-inch (0.015 cm) thickness. It can be advantageous for thecross-section of the arms and or wings of the expandable member to beasymmetrical. For example, the cross-section can be rectangular orelliptical such that one axis is substantially longer then itsorthogonal axis. The purpose of this asymmetry is to provide flexibilityin one direction and stiffness in the orthogonal direction. Thestiffness facilitates capture and manipulation of tissue, whileflexibility facilitates expansion and retraction of the expandablemember. In some or the same embodiments, the arms and/or wings areconfigured with rounded edges to minimize tissue trauma during use. Insome embodiments, the internal face of wings 464 a and 464 b can includevisual line marker(s) 470 that indicate an entry position for a needleassembly (not shown) that exits from the side of elongate assembly 450.

Other embodiments of structures that can be used to better engage andmanipulate target tissue, including the median lobe of the prostate, arecontemplated below. In some embodiments, wings 508 a and 508 b can bedeployed from an expandable member 500 using a pair of telescopic arms.As shown in FIGS. 13A-13D, wing 508 a is attached to or continuous witharm 502 b. Arms 502 a and 502 b can be coupled within sleeve 522 a suchthat arm 502 b glides along stationary arm 502 a (indicated by thedashed arrow in FIG. 13C) to transition from a contracted to an expandedstate while simultaneously transitioning wing 508 a outward from thelongitudinal axis of member 500 from a compressed (“closed”) to anexpanded (“open”) state. Expandable member 500 can be inserted into asheath for placement at an interventional site. Once the device ispositioned at the target site, the delivery device can be actuated todeploy arms 502 b and 502 d from sleeves 522 a and 522 b, respectively,to engage target tissue.

Alternative embodiments of telescopic arms are illustrated in FIGS. 14A& 14B. In FIG. 14A, interlocking arms 550 a and 550 b are shown. Arm 550a can house arm 550 b and include rounded ends 552 that cover the topand bottom edges of arm 550 b. In FIG. 14B, each of interlocking arms560 a and 560 b have a rounded end and a flat end. When interlocked, therounded end of each arm covers the flat end of the opposite arm.

In the telescopic arm design of FIGS. 13A-13D and FIGS. 14A & 14B, thestationary arms can be secured to the shaft of the elongate assembly ofthe delivery device. Such a design provides guided, stabilized alignmentand delivery of wings, or a similarly looped distal end, to aninterventional site.

Turning now to FIGS. 15A-D, an approach to engaging and manipulating anenlarged median lobe ML is presented. Such an approach can be used as acomplementary therapy with treatments for lateral lobes or can beemployed solely to treat a median lobe ML. Because an enlarged medianlobe ML can extend into the urinary bladder UB and may act as a ballvalve interfering with normal function (See FIGS. 15A and 15B; FIG. 13Bis a view through the prostatic urethra and into the urinary bladder),moving tissue away from a ball valve location (that is, away from thebladder neck) may be desired. By avoiding such invasive approaches (suchas TURP), there is significantly less risk of disrupting the nervetissue and/or the smooth muscle of the bladder neck. With lessdisruption to these tissues, ejaculating function and continencecomplications will likely be lower.

Accordingly, an approach involving inserting a device into the prostaticurethra UT transurethrally to compress and/or displace the median lobeML is contemplated. Once the lobe is compressed or displaced, otherprocedures such as implanting tissue anchors or implants in a specificdirection to maintain the compression/displacement of the median lobe.

As an initial step, sagittal views of a patient's bladder and prostatecan be taken using transabdominal or transrectal ultrasonography. Inthis way, the patient's anatomy can be assessed. In this regard, anintravesical prostate measurement is taken to determine the verticaldistance from a tip of the median lobe protrusion to the base of thebladder. As shown in FIGS. 15C-D, after assessing the anatomy, theelongate tissue access assembly 104 of an anchor delivery device (SeeFIGS. 8A and 8B) is advanced within the urethra UT and into appositionwith the median lobe ML. FIG. 15D is a view through the urethra UTdepicting the compression and displacement of the median lobe ML.

One specific series of actions is to position the tissue access assembly104 so that its terminal end 112 is anterior to a prominent portion ofthe median lobe ML and then displace the surface in the posteriordirection to move the median lobe ML away from a centerline of theurethra lumen UT. The median lobe consequently forms a tissue fold (SeeFIG. 15D) about the delivery instrument. In embodiments in which anexpandable member is used to engage and manipulate the median lobe, theexpandable member provides increased surface area as compared to tissueaccess assembly 104 in FIG. 15D, which facilitates temporary capture ofthe median lobe so that it can be displaced. In some embodiments, tissueof the median lobe can be captured in the space between the wings of theexpandable member and the distal end of the elongate tissue treatmentdevice. Thus, the wings of the expandable member can be configured topromote such capture, including by varying the amount of expansion thatthe wings undergo during deployment and retraction.

FIGS. 16A & 16B illustrate another embodiment of a looped or expandablemember. In this embodiment, a looped member 608 can be housed in thedistal end of a sheath 610 such that the expandable wing portion oflooped member 608 is compressed. When an elongate assembly is passedthrough sheath 610, it contacts the proximal end of looped member 608(not shown) and pushes the wing portion out of sheath 610, allowing itto expand and manipulate target tissue.

In some embodiments, a looped member 708 can be attached to the distalend of a sheath 710, as shown in FIGS. 17A & 17B. In these embodiments,looped member 708 can expand and/or manipulate tissue at aninterventional site prior to deployment of an elongate assembly. In someembodiments, looped member 708 can be made of a level ribbon, that is,having a linear cross-section. In other embodiments, looped member 708can be made of a semi-circular ribbon having a c-shaped cross-section toprevent the edges of the device from contacting patient tissue duringdelivery.

Alternative embodiments of an expandable member are shown in FIGS. 18A &18B and 19A & 19B. Expandable member 800 can include a pair of tubes 802and 812 attached to opposite sides of the shaft of an elongate assemblyof a delivery device (not shown). Such tubes can be biased to the distalend of the elongate assembly. Tubes 802 and 812 can house wires 804 and806, respectively, which are threaded through the lumen of the tube andthen exit the distal end of each tube. The wire that exists the tube ispositioned substantially parallel to the outer length of each tube andis bent, bowed, arced, or otherwise curved. As shown in FIGS. 18A & 16B,wire 804 includes a pair of expandable portions 804 a and 804 b with acinched waist 808 therebetween and wire 806 includes a pair ofexpandable portions 806 a and 806 b with a cinched waist 810therebetween. In some embodiments, the cinched waist of each wire can bea compression spring coil that allows the expandable portions tocollapse toward or expand from the midline of the elongate assembly.FIG. 18A illustrates expandable member 800 in a compressed or collapsedstate, such as when the elongate assembly is housed within a sheath (notshown). FIG. 18B illustrates expandable member 800 in an expanded state,such as when the elongate assembly exits the distal end of a sheath (notshown) freeing the springs to lengthen and, in turn, move the expandableportion of each wire away from the midline of the treatment device.FIGS. 19A and 19B illustrate another embodiment of expandable wirestructures that function similar to expandable member 800, butexpandable member 900 includes three expandable portions.

Various approaches are contemplated for best engaging median lobe orother tissue. Additional structural features can be incorporated intothe distal end of the expandable member of treatment device 100 for thepurpose of increasing frictional forces between the target tissue and adistal portion of the treatment device 100, or for increasing thesurface area of the treatment device. Knurled or roughened surfaces 952can form surface components of portions or an entirety of the winged orexpandable portions 950 (See FIG. 20A) of the treatment device 100. Insome embodiments, as shown in FIG. 20B one or more of spikes, fangs,hooks, barbs or other protuberances 954, or a combination thereof can beconfigured to extend at various angles and lengths from expandableportion 950. Such protuberances can be sharp or blunted. Such structurescan be one or more of retractable, flexible or fixed. Thus, in one ormore approaches, these structures can be associated with a pop-upfeature attached to a puller (not shown). In one aspect, control of theof the pop-up feature can be achieved with side actuators to deploy andretract extendable tissue engaging and manipulation features when sliddown the sheath and a spacer to change a relationship between the sheathand shaft for controlling deployment of the side actuators. In oneparticular approach, the spikes, fangs, hooks, barbs, or protuberancescan be angled proximally so that enhanced tissue engagement is providedwhen withdrawing the delivery device and is released when advancing thedelivery device.

Atraumatic tape can be placed over the spikes, fangs, hooks, barbs, orprotuberances 954 prior to use of the treatment device 100. The tape canbe removed prior to performing a median or middle lobe procedure. It isthus contemplated that the treatment system can be provided in twoconfigurations. A first configuration can be for normal use such that itincludes atraumatic tape that covers sharp or other tissue engagingfeatures and prevents them from interacting with the tissue. A secondconfiguration can be for median lobe engagement and manipulation usage,where the system is assembled and shipped without atraumatic tapecovering sharp or other tissue engaging features.

In some embodiments, tissue adhesive material 956 can be added to theexterior surface at various locations along expandable portion 950 (SeeFIG. 20C). In certain contemplated approaches, such tissue adhesivematerial 956 can range from adhesive tape to material that is swellablein fluid such that it changes its adhesion property when desired.Another contemplated approach to adhesion upon pressure involvesscale-like projections 958 (FIGS. 20F & 20G) incorporated ontoexpandable portion 950. High friction is created when pulling the targettissue in a direction against the scales, but no or little or lessfriction after deployment or when employing the treatment device 100with the direction of scales 958. Here also, such structure can be oneor more of retractable, flexible or fixed.

Structures that provide enhanced frictional or other engagement forcesalso can be based upon an adhesive that responds to pressure. Forexample, the expandable distal portion of treatment device 100 canadditionally or alternatively include micro-hooks similar to Velcrotechnology, the same requiring tissue to be pressed against it to createa secure engagement.

As stated, such tissue engaging structures can be placed in variouslocations along the expandable portion of treatment device 100. Texturesor protuberances can be configured to engage tissue such that tissuewill roll with the distal end of the device as it is rotated, forexample, into a deployment position. In some embodiments, the structurescan be located on side areas of the treatment device where there is morespace. That is, these structures can be located away from the exitpoints for the therapeutic elements that may extend from the treatmentdevice. It is specifically contemplated that structures can be locatedalong a “tissue contacting fence.” That is, protuberances can be hiddenfrom tissue contact in a “tissue contacting fence” and configured toextend beyond this protective fence via a user operated actuator.

Referring now to FIG. 20D-F, elongate tissue access assembly 104, and inparticular the distal end of elongate tissue access assembly 104, caninclude knurled or roughened surfaces 952, spikes, fangs, hooks, barbs,or protuberances 954 (and, optionally, atraumatic tape), and/or tissueadhesive material 956. In certain embodiments, one or both of theelongate tissue access assembly and the expandable member can containone or more of these features. That is, the embodiments described above,illustrated in FIGS. 20A-H, can be incorporated into treatment device100 to supplement, or enhance, the tissue engagement and manipulationcapacity of the expandable or winged portion of the device, of thedistal end of the elongate tissue access assembly, or both.

Vacuum forces can also be employed to facilitate engaging andmanipulating tissue. In this regard, a suction or vacuum source (notshown) can be incorporated into the expandable portion or attachedthereto, and a channel provided to communicate with the distal end ofthe treatment device 100. In this way, the vacuum forces can beinitiated and controlled when the treatment device 100 is positioned toengage and manipulate target tissue.

As shown in FIG. 21, in another approach, partial controlled deploymentof the needle 230 can be utilized to engage and manipulate targettissue. The needle 230 can be retracted for later full deploymentassociated with, for example, implantation of an anchor device.Additionally or alternatively, one or more supplemental, side-projectingneedles 609 (shown in dashed lines in FIG. 22) can be provided forengaging and manipulating purposes. Various approaches to reinforcingthe distal portion of the needle 230 also contemplated so that a morerobust structure is presented for tissue manipulation. For example, asupplemental needle tip 610 can be attached to a terminal and portion ofthe needle 230. In one contemplated approach, the needle tip 610 can beattached to structure that is configured to be actuated from thedelivery device handle. The needle 610 can define a solid member tothereby provide sufficient mechanical strength for manipulating tissue,and be connected to any elongated member that extends within thedelivery device which extends along and outside of the delivery devicebut within an introducer sheath or through fluid holes therein. Manualor automated approaches to control the use or removal of the needle tip610 are both envisioned.

With reference to FIG. 22, the distal end portion 104 of the deliverydevice 100 can also, additionally or alternatively, include a divot orrecess having a radius of curvature that matches, or generally receives,the contours of the median lobe or other target tissue. The interior ofthe recess can be configured with any of the described structures forengaging and manipulating tissue. For example, FIG. 22 illustratesrecess 616 as including a plurality of spikes 954. Referring now to FIG.23, a second or supplementary sheath 620 can be provided and configuredabout the distal portion 104 of delivery device 100. Sheath 620 itselfcan include one or more of the tissue engaging and manipulating featuresdescribed herein. Such features can be reserved for one or more sides orportions of the sheath 620 or can be positioned completely around sheath620. Additionally, sheath 620 itself can include recess 616 configuredto match tissue anatomy. Thus, recess 616 can be included in distal end104 of delivery device 100 by fabricating distal end 104 with a recess616, or by using sheath 620 that have been fabricated with a recess 616.

The target tissue or median lobe specifically can be pre-treated tofacilitate engagement with the treatment device 100. In this regard, itis contemplated that the target tissue can be subjected toelectro-cauterization, botox or other modality to alter its mechanicalprofile. The target tissue can alternatively or additionally bepre-treated by making incisions therein. Finally, the target tissue canbe lassoed to support the tissue or to accomplish the desiredmanipulations.

It is to be recognized that various materials are within the scope ofthe present disclosure for manufacturing the disclosed devices.Moreover, one or more components disclosed herein can be completely orpartially biodegradable or biofragmentable.

Further, as stated, the devices and methods disclosed herein can be usedto treat a variety of pathologies in a variety of lumens or organscomprising a cavity or a wall. Examples of such lumens or organsinclude, but are not limited to urethra, bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins (e.g. for treatingvaricose veins or valvular insufficiency), arteries, lymphatic vessels,ureters, bladder, cardiac atria or ventricles, uterus, fallopian tubes,etc.

Finally, it is to be appreciated that the disclosure has been describedhereabove with reference to certain examples or embodiments of thedisclosure but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the disclosure. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Briefly and in general terms, the present disclosure is directed towardsan apparatus and method for engaging and manipulating internal bodystructures. Such engagement and manipulation can form the primary oralternatively, form a supplementary or integral part of a multi-stepinterventional procedure. In one aspect, the apparatus includes elongatemember configured to engage tissue in order to manipulate or repositionthat tissue. In some embodiments, the tissue is a prostate. In someembodiments, the tissue is the median lobe of a prostate.

In various approaches, the apparatus can include a portion that isequipped with structure that increases frictional forces between theapparatus and tissue to be manipulated. The apparatus can additionallyor alternatively include an extendable needle that can be partiallydeployed to engage or manipulate target tissue. A retractable sheath canalso additionally or alternatively be provided to facilitate engagingand manipulating tissue. Further, the surface area of a distal endportion of the apparatus can include structure(s) intended to increasesurface area and thus present structure(s) specifically configured toeffectively engage or manipulate tissue. Moreover, the apparatus can beconfigured and employed to pre-treat target tissue by subjecting thetissue to energy or substances that alter the mechanical profile or bycreating incisions therein.

Thus, the delivery apparatus of the present disclosure can additionallyinclude various subassemblies which are mobilized via an actuator orother manually accessible structure. The operation of the subassembliesis coordinated and synchronized to ensure accurate and precisenavigation and placement of the tissue engaging or manipulationstructure.

Referring now to FIG. 24A-B, in some embodiments expandable member 200is adjustable. FIGS. 24A and 24B illustrate a distal end of elongatetissue access assembly 104 and expandable member 200 present on one sideof elongate tissue access assembly 104. That is, in this particularembodiment there is only one set of arms or wings. FIG. 24 A illustratesexpandable member 200 in an expanded state, while FIG. 24B illustratesexpandable member 200 in a contracted state. Median lobe ML can becaptured within the space between expandable member 200 and elongatetissue access assembly 104. Then, expandable member 200 can becontracted or cinched down such that median lobe ML is secured withinthe space between expandable member and elongate tissue access assembly104. In this position, median lobe ML can be manipulated and/ordisplaced.

Referring now to FIG. 25A-B, expandable member 200 can be adjusted froma larger size (FIG. 25A) to a smaller size (FIG. 25B) in embodiments inwhich expandable member 200 includes two or more sets of arms and wings.In these embodiments, expandable member 200 can be used to capturetissue in the space between expandable member 200 and elongate tissueaccess assembly 104, or expandable member 200 can be used to manipulateand/or displace tissue according to other embodiments disclosed herein.The individual arms of expandable member 200 can be adjustedindividually or together.

In the embodiments in which expandable member 200 can be adjusted, it iscontemplated that the adjustments can occur prior to putting the devicein the patient (or prior to putting the device within the sheath in theembodiments in which a sheath is used) or the adjustments can occur ator near the site of tissue manipulation within the patient. A physiciancan set the size of expandable member 200 based on the patient'sanatomy, for example. The physician may be able to determine the desiredsize for expandable member 200 based on measurement and/or observationof the patient's anatomy prior to and/or during a procedure.

Referring now to FIGS. 26A-B and 27A-B, the handle of device 100 caninclude wheel 1000 or slider 1100, each of which are coupled toexpandable member 200 and configured to expand or contract expandablemember 200. In certain embodiments, wheel 1000 and slider 1100 providecontinuous adjustability from a “Small” expansion size to a “Medium”expansion size to a “Large” expansion size, where the extent ofexpansion is indicated with a tactile indicator. Optionally, a lock isprovided on wheel 1000 or slider 1100 such that the size of theexpandable member can be fixed. In certain other embodiments, wheel 1000and slider 1100 provide discrete adjustability from a “Small” expansionsize to a “Medium” expansion size to a “Large” expansion size. That is,there are two or more pre-set sizes for expandable member 200 and wheel1000 or slider 1100 allow for the physician to elect between or amongthose sizes only.

Various alternative methods of use are contemplated. The disclosedapparatus can be used to facilitate improving flow of a body fluidthrough a body lumen, modify the size or shape of a body lumen orcavity, treat prostate enlargement, treat urinary incontinence, supportor maintain positioning of a tissue, close a tissue wound, organ orgraft, perform a cosmetic lifting or repositioning procedure, formanastomotic connections, and/or treat various other disorders where anatural or pathologic tissue or organ is pressing on or interfering withan adjacent anatomical structure. Also, the disclosure has a myriad ofother potential surgical, therapeutic, cosmetic or reconstructiveapplications, such as where a tissue, organ, graft or other materialrequires approximately, retracting, lifting, repositioning, compressionor support.

One aspect of the invention is a system for engaging and manipulating amedian lobe of a prostate gland that includes a sheath and a tissueengaging or manipulation device housed within the sheath, the tissueengaging or manipulation device being sized and shaped to be insertedwithin a patient's urethra and to extend within prostate tissue, thetissue engaging or manipulation device including a moveable engagementstructure that can transition from a compressed state to an expandedstate to enhance contact with the median lobe, wherein the engagementstructure is biased to a distal end of the tissue engaging ormanipulation device.

In another aspect of the invention, the engagement structure comprises afirst arm and a second arm anchored to opposite sides of a shaft of thetissue engaging or manipulation device.

In another aspect of the invention, the first arm comprises a firstexpandable portion and the second arm comprises a second expandableportion, wherein the first expandable portion and the second expandableportion compress toward the shaft when the tissue engaging ormanipulation device is housed in the sheath.

In another aspect of the invention, the first expandable portion and thesecond expandable portion expand away from the shaft when the tissueengaging or manipulation device exits the sheath.

In another aspect of the invention, the engagement structure furthercomprises a channel to receive and secure a portion of the distal end ofthe tissue engaging or manipulation device.

In another aspect of the invention, when the distal end of the tissueengaging or manipulation device is secured in the channel, movement ofthe engagement structure is constrained to a longitudinal axis of thetissue engaging or manipulation device.

In another aspect of the invention, movement along the longitudinal axisof the tissue engaging or manipulation device confers the transition ofthe engagement structure from the compressed state to the expandedstate.

In another aspect of the invention, the engagement structure is madefrom a ribbon with a plurality of round edges to reduce trauma totissue, wherein the ribbon is assymetrical in cross-section.

In another aspect of the invention, the engagement structure is madefrom a ribbon with a c-shaped cross-section that reduces trauma totissue.

In another aspect of the invention, the shaft of the tissue engaging ormanipulation device further comprises a side aperture and a needleassembly that exits from the side aperture, wherein the side aperture isaligned between the first expandable portion and the second expandableportion of the engagement structure.

In another aspect of the invention, the first expandable portionincludes an internal face with a first visual line marker and the secondexpandable portion includes an internal face and a second visual linemarker.

In another aspect of the invention, the first visual line marker and thesecond visual line marker of the engagement structure indicate thetissue entry position for the needle assembly after exiting the sideaperture.

In another aspect of the invention, the first arm and the second arm ofthe engagement structure are configured to be telescopic.

In another aspect of the invention, the engagement structure is a loopaffixed to a terminal portion of a shaft of the tissue engaging ormanipulation device.

In another aspect of the invention, the loop is flexible and configuredto compress toward the shaft when the tissue engaging or manipulationdevice is housed in the sheath and expand when the tissue engaging ormanipulation device exits the sheath.

In another aspect of the invention, the engagement structure isadjustable prior to or during a procedure, and the adjustment can becontinuous or discrete via a control device on the handle of the system.

In another aspect of the invention, the engagement structure isconfigured to enhance frictional contact with the median lobe.

In another aspect of the invention, the engagement structure includesone or more of spikes, fangs, hooks, barbs or other protuberancesarranged at various angles and having various lengths.

In another aspect of the invention, the engagement structure is definedby a knurled surface.

In another aspect of the invention, the engagement structure is definedby an adhesive surface, which optionally may be swellable.

In another aspect of the invention, the engagement structure is definedby scales.

In another aspect of the invention the system includes a firstprojectable needle and a second projectable needle.

In another aspect of the invention, a reinforcing structure is affixedto a terminal and of one or more of the first and second project ofneedles.

In another aspect of the invention, the engagement structure includesand atraumatic tape that is configured to cover the engagementstructure.

In another aspect of the invention, the engagement structure is definedby a divot formed on a portion of the distal end of the system, thedivot sized and shaped to substantially fit a contour both targettissue.

In another aspect of the invention, tissue is pre-treated prior to beingmanipulated by an engagement structure, and the pre-treatment includesone or more of electro-cauterizing, botox, or incisions.

Thus, it will be apparent from the foregoing that, while particularforms of the disclosure have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe disclosure.

We claim:
 1. A treatment device for engaging and manipulating a medianlobe of a prostate gland, comprising: an elongate tissue access assemblycoupled to a handle assembly, wherein the elongate tissue accessassembly is configured to be inserted within an introducer sheath; and atissue engagement structure attached to a distal end portion of theelongate tissue access assembly, wherein the tissue engagement structurecan transition from a contracted state to an expanded state when theelongate tissue access assembly exits a distal end of the introducersheath.
 2. The treatment device of claim 1, wherein the tissueengagement structure comprises a first expandable portion having anasymmetrical cross-section.
 3. The treatment device of claim 2, whereina proximal portion of the first expandable portion is attached to theelongate tissue access assembly.
 4. The treatment device of claim 1,wherein the tissue engagement structure comprises a channel to receivethe distal end portion of the elongate tissue access assembly.
 5. Thetreatment device of claim 1, wherein movement of the tissue engagementstructure relative to the elongate tissue access assembly is constrainedto be along a longitudinal axis of the elongate tissue access assembly.6. The treatment device of claim 5, wherein movement of the tissueengagement structure relative to the elongate tissue access assemblytransitions the tissue engagement structure from the contracted state tothe expanded state.
 7. The treatment device of claim 1, wherein theelongate tissue access assembly further comprises an aperture and aneedle assembly that is extendable through the aperture.
 8. Thetreatment device of claim 7, wherein the tissue engagement structurefurther comprises a first visual marker indicating a tissue entryposition for the needle assembly.
 9. The treatment device of claim 2,wherein the tissue engagement structure further comprises a secondexpandable portion having an asymmetrical cross-section.
 10. Thetreatment device of claim 9, wherein the elongate tissue access assemblyfurther comprises an aperture and a needle assembly that is extendablethrough the aperture.
 11. A system for engaging and manipulating amedian lobe of a prostate gland, comprising: an anchor delivery devicecomprising an elongate tissue access assembly, wherein the elongatetissue access assembly is configured to be inserted within an introducersheath; a tissue anchor housed within the anchor delivery device; atissue engagement structure attached to a distal end portion of theelongate tissue access assembly, wherein the tissue engagement structurecan transition from a contracted state to an expanded state.
 12. Thesystem of claim 1, wherein the tissue engagement structure comprises afirst expandable portion having an asymmetrical cross-section.
 13. Thesystem of claim 12, wherein a proximal portion of the first expandableportion is fixedly attached to the elongate tissue access assembly. 14.The system of claim 11, wherein the tissue engagement structurecomprises a slidable portion coupled to the elongate tissue accessassembly.
 15. The system of claim 11, wherein movement of the tissueengagement structure relative to the elongate tissue access assemblytransitions the tissue engagement structure from the contracted state tothe expanded state.
 16. The system of claim 11, wherein the anchordelivery device further comprises a needle assembly.
 17. The system ofclaim 16, wherein the needle assembly is configured to deliver thetissue anchor.
 18. The system of claim 17, wherein the tissue engagementstructure comprises a first expandable portion.
 19. The system of claim18, wherein the first expandable portion further comprises a firstvisual marker indicating a tissue entry position for the needleassembly.
 20. The system of claim 12, wherein the tissue engagementstructure further comprises a second expandable portion.